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Job #03147

About our client Our client is a leading pharmaceutical company focused on the development and commercialization of various therapeutics in disease prevention, aimed at improving the quality of life for everyone worldwide. The company has an experienced management team, a varied selection of protocols and an empowering corporate culture that is focused on the long-term development of its employees. Position Location Senior Scientist Ridgefield, New Jersey Salary Highly competitive package, commensurate with experience Responsibilities 1) Plan, design, direct, execute and summarize assigned clinical pharmacology department clinical studies 2) Work closely with and direct the Operations staff on studies 3) Develop long range plans and budgets for studies assigned 4) Participate in the preparation of regulatory documents (e.g. NDA documents, investigators brochures, etc.) 5) Develop new methodologies to explore clinical pharmacology aspects of select compounds 6) Plan, design and direct clinical pharmacology department studies in various therapeutic categories 7) Develop working practice documents and relevant formal training programs 8) Function as a Study Director for assigned studies 9) Direct the activities of monitors assigned to clinical studies with regard to protocol and CRF design 10) Identify qualified clinical investigators 11) Negotiate clinical study budgets 12) Monitor regular activities and verify data 13) Handle clinical supplies and interact with BCDM and PKDM Requirements 1) Doctoral (Pharm.D. or Ph. D.) level degree (or in some cases a Master’s degree) 2) Minimum 5 years of experience in clinical research in the pharmaceutical industry 3) In-depth understanding of clinical research methodology including study design, protocol writing and CRF preparation 4) Knowledge of GCP and local regulatory requirements 5) Knowledge of the IND/NDA process acquired through direct industrial experience 6) Knowledge of medical, scientific and clinical research techniques in assigned therapeutic area